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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I/II Pilot Study of a Multi-Epitope Peptide Vaccine With Sargramostim (GM-CSF) Plasmid DNA Immune Adjuvant in Patients With Stage IIB, IIC, III, or IV Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed Any age (weight > 25 kg) NCI MSKCC-00142A 5906, NCI-5906, NCT00085137

Trial Description

Purpose:

Vaccines may make the body build an immune response to kill tumor cells. Combining an immune adjuvant with a vaccine may cause a stronger immune response and kill more tumor cells.

This phase I/II trial is studying the side effects and best dose of immune adjuvant when given together with vaccine therapy and to see how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.

Eligibility:

Eligibility criteria include the following:

• Any age if weight is more than 55 lb (25 kg)
• No brain metastases
• More than 4 weeks since biological therapy, chemotherapy, or radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an injection of the immune adjuvant on day 1. On day 5 they will receive an injection of the vaccine. Treatment may be repeated every 4 weeks for up to three courses. Patients will be evaluated at least once a year for at least 15 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Miguel-Angel Perales, MD, Principal investigator		Ph: 212-639-8682; 800-525-2225
Paul Chapman, MD, Principal investigator		Ph: 646-888-2378; 800-525-2225
Alan Houghton, MD, Principal investigator		Ph: 212-639-7595; 800-525-2225
Jedd Wolchok, MD, Principal investigator		Ph: 646-888-2395; 800-525-2225

Registry Information
Official Title		Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity
Trial Start Date		2003-12-30
Registered in ClinicalTrials.gov		NCT00085137
Date Submitted to PDQ		2004-04-16
Information Last Verified		2006-08-15
NCI Grant/Contract Number		CA33049, CA08748

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